82 FR 46076 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46076-46078 | |
| FR Document | 2017-21171 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46076-46078] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21171] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4918] Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. [[Page 46077]] DATES: The public meeting will be held on November 1, 2017, from 8 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-4918. The docket will close on October 27, 2017. Submit either electronic or written comments on this public meeting by October 27, 2017. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 27, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 27, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before October 17, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-4918 for ``Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss new drug application (NDA) 210136, buprenorphine subcutaneous injection, submitted by Braeburn Pharmaceuticals, Inc., for treatment of opioid dependence. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. All electronic and written submissions submitted to [[Page 46078]] the docket (see the ADDRESSES section) on or before October 17, 2017, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 6, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 10, 2017. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Kalyani Bhatt at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21171 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
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• Confidential Submissions—To Ave., Bldg. 1672, Silver Spring, MD requirements of the applicable statutes
submit a comment with confidential 20993–0002, 301–796–9291. and regulations. This draft guidance is
information that you do not wish to be SUPPLEMENTARY INFORMATION: not subject to Executive Order 12866.
made publicly available, submit your
I. Background II. The Paperwork Reduction Act of
comments only as a written/paper
1995
submission. You should submit two FDA is announcing the availability of
copies total. One copy will include the a draft guidance for industry entitled This draft guidance refers to
information you claim to be confidential ‘‘ANDAs for Certain Highly Purified previously approved collections of
with a heading or cover note that states Synthetic Peptide Drug Products That information that are subject to review by
‘‘THIS DOCUMENT CONTAINS Refer to Listed Drugs of rDNA Origin.’’ the Office of Management and Budget
CONFIDENTIAL INFORMATION.’’ The In general, for FDA to approve an ANDA (OMB) under the Paperwork Reduction
Agency will review this copy, including submitted under section 505(j) of the Act of 1995 (44 U.S.C. 3501–3520). The
the claimed confidential information, in FD&C Act, an ANDA applicant must collection of information required under
its consideration of comments. The demonstrate, among other things, that 21 CFR part 314 for the submission of
second copy, which will have the the proposed generic drug has the NDAs and ANDAs is approved under
claimed confidential information ‘‘same’’ active ingredient(s) as and is OMB control number 0910–0001, and
redacted/blacked out, will be available bioequivalent to its reference listed the submission of controlled
for public viewing and posted on drug, and that the methods used in, and correspondence pertaining to ANDAs is
https://www.regulations.gov. Submit the facilities and controls used for, the approved under OMB control number
both copies to Dockets Management manufacture, processing, and packing of 0910–0797.
Staff. If you do not wish your name and the proposed generic drug are adequate III. Electronic Access
contact information to be made publicly to assure and preserve its identity,
available, you can provide this strength, quality, and purity (sections Persons with access to the internet
information on the cover sheet and not 505(j)(2)(A) and (4) (21 U.S.C. may obtain the draft guidance at either
in the body of your comments and you 355(j)(2)(A) and (4)) of the FD&C Act). https://www.fda.gov/Drugs/Guidance
must identify this information as If a person is seeking approval of a ComplianceRegulatoryInformation/
‘‘confidential.’’ Any information marked synthetic peptide drug product Guidances/default.htm or https://www.
as ‘‘confidential’’ will not be disclosed (specifically glucagon, liraglutide, regulations.gov.
except in accordance with 21 CFR 10.20 nesiritide, teriparatide, or teduglutide) Dated: September 28, 2017.
and other applicable disclosure law. For and intends to submit an application Anna K. Abram,
more information about FDA’s posting that refers to a previously approved Deputy Commissioner for Policy, Planning,
of comments to public dockets, see 80 peptide drug product of rDNA origin, if Legislation, and Analysis.
FR 56469, September 18, 2015, or access the active ingredient in the proposed [FR Doc. 2017–21202 Filed 10–2–17; 8:45 am]
the information at: https://www.gpo.gov/ synthetic peptide drug product can be BILLING CODE 4164–01–P
fdsys/pkg/FR-2015-09-18/pdf/2015- shown to be the same as the active
23389.pdf. ingredient in the peptide drug product
Docket: For access to the docket to of rDNA origin, whether the application DEPARTMENT OF HEALTH AND
read background documents or the should be submitted as an ANDA under HUMAN SERVICES
electronic and written/paper comments section 505(j) of the FD&C Act or as a
received, go to https:// new drug application under section Food and Drug Administration
www.regulations.gov and insert the 505(b) of the FD&C Act will depend
docket number, found in brackets in the largely on the impurity profile for the [Docket No. FDA–2017–N–4918]
heading of this document, into the synthetic peptide drug product as
Joint Meeting of the
‘‘Search’’ box and follow the prompts compared to the impurity profile for the
Psychopharmacologic Drugs Advisory
and/or go to the Dockets Management peptide drug product of rDNA origin.
Committee and the Drug Safety and
Staff, 5630 Fishers Lane, Rm. 1061, Differences in impurities, particularly
Risk Management Advisory
Rockville, MD 20852. peptide-related impurities, may affect
Committee; Notice of Meeting;
You may submit comments on any the safety or effectiveness of a peptide
Establishment of a Public Docket;
guidance at any time (see 21 CFR drug product. This draft guidance is
Request for Comments
10.115(g)(5)). intended to assist potential applicants
in determining when an application for AGENCY: Food and Drug Administration,
Submit written requests for single a synthetic peptide drug product that HHS.
copies of the draft guidance to the refers to a previously approved peptide
Division of Drug Information, Center for ACTION: Notice; establishment of a
drug product of rDNA origin should be public docket; request for comments.
Drug Evaluation and Research, Food submitted as an ANDA rather than an
and Drug Administration, 10001 New NDA. SUMMARY: The Food and Drug
Hampshire Ave., Hillandale Building, This draft guidance is being issued Administration (FDA or Agency)
4th Floor, Silver Spring, MD 20993– consistent with FDA’s good guidance announces a forthcoming public
0002. Send one self-addressed adhesive practices regulation (21 CFR 10.115). advisory committee meeting of the
label to assist that office in processing
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The draft guidance, when finalized, will Psychopharmacologic Drugs Advisory
your requests. See the SUPPLEMENTARY represent the current thinking of FDA Committee and the Drug Safety and Risk
INFORMATION section for electronic
on the submission of ANDAs for certain Management Advisory Committee. The
access to the draft guidance document. highly purified synthetic peptide drug general function of the committee is to
FOR FURTHER INFORMATION CONTACT: Gail products that refer to listed drugs of provide advice and recommendations to
Schmerfeld, Office of Generic Drugs, rDNA origin. It does not establish any the Agency on FDA’s regulatory issues.
Center for Drug Evaluation and rights for any person and is not binding The meeting will be open to the public.
Research, Food and Drug on FDA or the public. You can use an FDA is establishing a docket for public
Administration, 10903 New Hampshire alternative approach if it satisfies the comment on this document.
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![46078 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
the docket (see the ADDRESSES section) DEPARTMENT OF HEALTH AND that if you include your name, contact
on or before October 17, 2017, will be HUMAN SERVICES information, or other information that
provided to the committees. Oral identifies you in the body of your
presentations from the public will be Food and Drug Administration comments, that information will be
scheduled between approximately 1 [Docket No. FDA–2017–D–5139] posted on https://www.regulations.gov.
p.m. and 2 p.m. Those individuals • If you want to submit a comment
interested in making formal oral M4 Organization of the Common with confidential information that you
presentations should notify the contact Technical Document for the do not wish to be made available to the
Registration of Pharmaceuticals for public, submit the comment as a
person and submit a brief statement of
Human Use; International Council for written/paper submission and in the
the general nature of the evidence or
Harmonisation; Guidance for Industry; manner detailed (see ‘‘Written/Paper
arguments they wish to present, the Submissions’’ and ‘‘Instructions’’).
names and addresses of proposed Availability
participants, and an indication of the AGENCY: Food and Drug Administration, Written/Paper Submissions
approximate time requested to make HHS. Submit written/paper submissions as
their presentation on or before October ACTION: Notice of availability. follows:
6, 2017. Time allotted for each • Mail/Hand delivery/Courier (for
presentation may be limited. If the SUMMARY: The Food and Drug written/paper submissions): Dockets
number of registrants requesting to Administration (FDA or Agency) is Management Staff (HFA–305), Food and
speak is greater than can be reasonably announcing the availability of a Drug Administration, 5630 Fishers
guidance for industry (GIF) entitled ‘‘M4 Lane, Rm. 1061, Rockville, MD 20852.
accommodated during the scheduled
open public hearing session, FDA may
Organization of the Common Technical • For written/paper comments
Document for the Registration of submitted to the Dockets Management
conduct a lottery to determine the Pharmaceuticals for Human Use.’’ The Staff, FDA will post your comment, as
speakers for the scheduled open public guidance was prepared under the well as any attachments, except for
hearing session. The contact person will auspices of the International Council for information submitted, marked and
notify interested persons regarding their Harmonisation (ICH), formerly the identified, as confidential, if submitted
request to speak by October 10, 2017. International Conference on as detailed in ‘‘Instructions.’’
Persons attending FDA’s advisory Harmonisation. The guidance updates Instructions: All submissions received
committee meetings are advised that the the Quality-related sections of the must include the Docket No. FDA–
Agency is not responsible for providing Granularity Document Annex, Module 2017–D–5139 for ‘‘M4 Organization of
access to electrical outlets. 2.3 Quality Overall Summary, and the Common Technical Document for
Module 3 Quality. The guidance is the Registration of Pharmaceuticals for
FDA welcomes the attendance of the
intended to provide recommendations Human Use; International Council for
public at its advisory committee on the organization of the common Harmonisation; Guidance for Industry;
meetings and will make every effort to technical document (CTD)/eCTD and Availability.’’ Received comments will
accommodate persons with disabilities. replaces the August 2001 FDA guidance be placed in the docket and, except for
If you require special accommodations for industry ‘‘M4: Organization of the those submitted as ‘‘Confidential
due to a disability, please contact CTD’’ and the October 2005 FDA Submissions,’’ publicly viewable at
Kalyani Bhatt at least 7 days in advance guidance for industry ‘‘Granularity https://www.regulations.gov or at the
of the meeting. Document Annex to M4: Organization of Dockets Management Staff between 9
FDA is committed to the orderly the CTD.’’ a.m. and 4 p.m., Monday through
conduct of its advisory committee DATES: The announcement of the Friday.
meetings. Please visit our Web site at guidance is published in the Federal • Confidential Submissions—To
https://www.fda.gov/Advisory Register on October 3, 2017. submit a comment with confidential
Committees/AboutAdvisoryCommittees/ ADDRESSES: You may submit either information that you do not wish to be
ucm111462.htm for procedures on electronic or written comments on made publicly available, submit your
public conduct during advisory Agency guidances at any time as comments only as a written/paper
follows: submission. You should submit two
committee meetings.
copies total. One copy will include the
Notice of this meeting is given under Electronic Submissions information you claim to be confidential
the Federal Advisory Committee Act (5 Submit electronic comments in the with a heading or cover note that states
U.S.C. app. 2). following way: ‘‘THIS DOCUMENT CONTAINS
Dated: September 27, 2017. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Anna K. Abram,
https://www.regulations.gov. Follow the Agency will review this copy, including
instructions for submitting comments. the claimed confidential information, in
Deputy Commissioner for Policy, Planning,
Comments submitted electronically, its consideration of comments. The
Legislation, and Analysis.
including attachments, to https:// second copy, which will have the
[FR Doc. 2017–21171 Filed 10–2–17; 8:45 am]
www.regulations.gov will be posted to claimed confidential information
BILLING CODE 4164–01–P the docket unchanged. Because your redacted/blacked out, will be available
asabaliauskas on DSKBBXCHB2PROD with NOTICES
comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, contact information to be made publicly
such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
as a manufacturing process. Please note must identify this information as
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Document Created: 2017-10-03 01:01:39
Document Modified: 2017-10-03 01:01:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; establishment of a public docket; request for comments. | |
| Dates | The public meeting will be held on November 1, 2017, from 8 a.m. to 5 p.m. | |
| Contact | Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 82 FR 46076 |
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